Title
FDA Bans Mercury-Contaminated Cosmetics
Law
Fda Circular No. 2010-015
Decision Date
Aug 13, 2010
The FDA has declared several cosmetic products, including St. Dalfour Beauty Whitening Cream and various Beauty Girl creams, as imminently dangerous due to excessive mercury levels, authorizing immediate seizure from public sale to protect consumer health.
administrative law
product safety
food and

Findings: mercury contamination threshold

  • The FDA finds that the listed cosmetic samples contain heavy metal (Mercury) exceeding the allowable limit of 1ppm.
  • The circular treats mercury contamination exceeding 1ppm as creating imminent danger or injury to the consuming public.
  • The circular links the contamination finding to violations of Republic Act No. 9711 and the Food and Drug Administration Act of 2009.

Identified cosmetic products barred

  • St. Dalfour Beauty Whitening Cream (brand: St. Dalfour; preparation: Cream; manufacturer/distributor: Tokyo, Japan) is covered.
  • Beauty Girl Papaya & Hawthorn Essence (10Double Whitening Speckles Removed Essence) (brand: Beauty Girl; preparation: Cream; manufacturer/distributor: Yudantang International a Taiwan) is covered.
  • Beauty Girl Ginseng & Green Cucumber (10 Double Whitening Speckles Removed) (brand: Beauty Girl; preparation: Cream; manufacturer/distributor: Yudantang International a Taiwan) is covered.
  • Beauty Girl Essence Aloe Pearl (10 Double Whitening Speckles Removed Essence) (brand: Beauty Girl; preparation: Cream; manufacturer/distributor: Yudantang International a Taiwan) is covered.
  • Beauty Girl Olive & Sheep Essence (10 DoubleWhitening Speckles Removed Essence) (brand: Beauty Girl; preparation: Cream; manufacturer/distributor: Yudantang International a Taiwan) is covered.

Legal basis and declared public-health purpose

  • Section 12 of Republic Act No. 9711 authorizes seizure action to protect public health and safety.
  • The circular’s declared purpose is the protection of public health and safety.
  • The circular states that selling or offering the identified products is in direct violation of Republic Act No. 9711 (the Food and Drug Administration Act of 2009) when the products are found to be imminently injurious, unsafe, or dangerous.

Prohibited acts and enforcement action

  • The circular authorizes enforcement action against the identified products that are on public sale or distribution.
  • FDA Food and Drug Regulation Officers (Central and regional) are ordered to seize immediately the identified cosmetic products.
  • Seizure is for custody from all outlets or establishments where the products are found.
  • The seizure covers the specific products listed in the circular, based on the FDA laboratory findings of mercury levels exceeding 1ppm.

Reporting assistance by LGUs and consumers

  • Local government units are requested to assist in reporting outlets or establishments found selling the identified products.
  • Consumers are requested to report outlets or establishments found selling the identified products.
  • Reporting is aimed at locating and preventing continued public sale or distribution of the covered products.

Adoption date and signatory

  • The circular is Adopted: 31 August 2010.
  • The circular is signed by (SGD.) NAZARITA T. TACANDONG, RPH, MPA, Acting Director IV.

Effectivity (publication/availability rule)

  • The circular is issued as FDA Circular No. 2010-015, August 13, 2010, and is adopted on 31 August 2010.

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